Method of treating prolapse of a vagina

ABSTRACT

A method of treating prolapse of a vagina includes supporting the vagina by implanting a sacrocolpopexy support and locating an exterior surface of the vagina between leg portions of a vaginal cuff section of the support, and securing a head section of the support to a ligament or a sacrum while isolating the head section from contact with tissue of the vagina.

BACKGROUND

Some women experience a reduction in the strength in the structure ofthe pelvic floor. A reduction in the strength of the pelvic floormuscles or in the supportive structure of the tissues in the pelvicfloor can lead to the reduced support of one or more of the pelvicorgans. Pelvic organs that have reduced support can prolapse, ordescend, through the pelvic floor. This condition is referred to aspelvic organ prolapse. For example, rectocele refers to the prolapse ofthe anterior wall of the rectum downward and into the posterior wall ofthe vagina. Cystocele refers to the prolapse of the bladder downward andinto the vagina. Vaginal prolapse refers to the prolapse of the cuff ofthe vagina downward through the vaginal opening, which can occur afterremoval of the uterus (or after removal of the uterus and the cervix).Sacrocolpopexy is a compound word that means fixation (pexy) of thevagina (colpo) to the sacrum or other sacral (sacro) tissue, usuallywith the aid of an implanted support. Sacralcolpopexy is synonymous withsacrocolpopexy.

SUMMARY

Embodiments provide a sacrocolpopexy support having a head sectionconnected to a leg section. The head section is attachable to the sacrumor to ligaments attached to the sacrum and the leg section is attachedto walls of the vagina. The head section is strong and suited forattachment to the sacrum. The leg section is supple and suited forattachment to the sensitive tissues of the vagina. The head section isformed from a material that has more weight and more strength than theleg section material. Embodiments described in this application providea closed joint structure within the leg section that is configured toisolate or separate the heavier head section material away from thelighter weight leg section material that is attached to the sensitivevaginal tissues. Advantages of these embodiments include supporting thevagina with the more supple and lighter weight leg section of thesupport while anchoring the support to the tough tissue of the sacrum orthe ligaments with the heavier weight material of the head section. Someadvantages of the closed joint leg section structure include thereduction in the possibility of the heavier weight head section rubbingagainst the sensitive tissue of the vagina.

One embodiment provides a sacrocolpopexy support having a head sectionconnected to a leg section. The head section extends from a first endportion to a second end portion. The leg section has a middle portion, afirst leg portion extending from the middle portion to a first end ofthe leg section, and a second leg portion extending from the middleportion to a second end of the leg section. A fold is formed in the legsection such that the first leg portion is folded into contact with thesecond leg portion. A first connector connects the head section to thefirst leg portion, where the first connector is not coupled to thesecond leg portion. A second connector connects the first leg portion tothe second leg portion, where the second connector is not coupled to thehead section. The first connector is coupled through not more than twolayers of the support, and the second connector is also coupled throughnot more than two layers of the support.

One embodiment provides a sacrocolpopexy support having a head sectionextending from a first end portion to a second end portion, and a legsection having a middle portion, a first leg portion extending from themiddle portion to a first end of the leg section, and a second legportion extending from the middle portion to a second end of the legsection. A fold is formed in the leg section such that the first legportion is folded into contact with the second leg portion. A firstconnector secures the head section to the first leg portion and does notsecure the head section to the second leg portion. A second connectorsecures the head section to the first leg portion and secures the headsection to the second leg section. The first connector is coupledthrough not more than two layers of the support, and the secondconnector is coupled through three layers of the support.

One embodiment provides a sacrocolpopexy support having a head sectionconnected to a leg section. The leg section has a first leg portionoverlaying, or positioned atop, a second leg portion such that the firstleg portion is arranged for attachment to an anterior wall of the vaginaand the second leg portion is arranged for attachment to a posteriorwall of the vagina. A connector connects the head section to the legsection, where the connector closes the first leg portion against thesecond leg portion to provide a closed joint that ensures that the headsection is segregated away from the anterior and posterior walls of thevagina. In one embodiment, a single connector is employed to bothconnect the head section to the leg section and to close the first legportion against the second leg portion.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments andtogether with the description serve to explain principles ofembodiments. Other embodiments and advantages of embodiments will bereadily appreciated as they become better understood by reference to thefollowing detailed description. The elements of the drawings are notnecessarily to scale relative to each other. Like reference numeralsdesignate corresponding similar parts.

FIG. 1 is a perspective view of one embodiment of a sacrocolpopexysupport.

FIG. 2 is a right side view of the sacrocolpopexy support illustrated inFIG. 1 .

FIG. 3 is a right side view of showing a connector between a leg sectionand a head section of the sacrocolpopexy support.

FIG. 4A and FIG. 4B are perspective views and FIG. 4C is a sideschematic view of the leg section connected to the head section.

FIG. 5 is a front side view of the sacrocolpopexy support illustrated inFIG. 1 .

FIG. 6 is a back side view of the sacrocolpopexy support illustrated inFIG. 1 .

FIG. 7 is a schematic view of the sacrocolpopexy support illustrated inFIG. 1 implanted in a patient.

FIG. 8 is a schematic side view of the sacrocolpopexy supportillustrated in FIG. 1 secured to a vagina of the patient.

FIG. 9 is a perspective view of one embodiment of a sacrocolpopexysupport.

FIG. 10 is a right side view of the sacrocolpopexy support illustratedin FIG. 9 .

FIG. 11A and FIG. 11B are perspective views of a leg section connectedto a head section of the sacrocolpopexy support.

FIG. 12 is a side schematic view of the leg section connected to thehead section of the sacrocolpopexy support.

FIG. 13 is a front side view of the sacrocolpopexy support illustratedin FIG. 9 .

FIG. 14 is a back side view of the sacrocolpopexy support illustrated inFIG. 9 .

FIG. 15 is a schematic side view of the sacrocolpopexy supportillustrated in FIG. 9 secured to a vagina of the patient.

FIG. 16 is a schematic side view of one embodiment of a sacrocolpopexysupport.

FIG. 17 is a schematic side view of one embodiment of a sacrocolpopexysupport.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific embodiments in which the invention maybe practiced. In this regard, directional terminology, such as “top,”“bottom,” “front,” “back,” “leading,” “trailing,” etc., is used withreference to the orientation of the Figure(s) being described. Becausecomponents of embodiments can be positioned in a number of differentorientations, the directional terminology is used for purposes ofillustration and is in no way limiting. It is to be understood thatother embodiments may be utilized and structural or logical changes maybe made without departing from the scope of the present invention. Thefollowing detailed description, therefore, is not to be taken in alimiting sense, and the scope of the present invention is defined by theattached claims.

The various exemplary embodiments described in this application may becombined with each other, unless specifically noted otherwise.

The term “proximal” in this application means that part that is situatednext to or near the point of attachment or origin or a central point;for example, as located toward a center of the human body. The uterus isproximal relative to abdominal skin of the patient.

The term “distal” in this application means that part that is situatedaway from the point of attachment or origin or the central point; forexample, as located away from the center of the human body. Theabdominal skin is distal relative to the internal organs, such as thevagina or the uterus of the patient.

End means endmost. A distal end is the furthest endmost location of adistal portion of a thing being described, whereas a proximal end is thenearest endmost location of a proximal portion of the thing beingdescribed. The portion next to or adjacent to an end is an end portion.For example, a 12-inch ruler has a center at 6 inches, a first end atzero inches and a second, opposite end at 12 inches, an end portionadjacent to the first end and another end portion adjacent to the secondend.

The term “basis weight” means weight per area. One acceptable unit forbasis weight is expressed as g/m².

A sacrocolpopexy support secures a prolapsed vaginal vault by anchoringor connecting the vaginal vault to one of the sacrum or ligamentsassociated with the sacrum. When the support is implanted, thepreviously prolapsed vaginal vault is supported or held up by thesupport that is connected between the tough sacrum/ligament tissues andthe vagina. The sacrocolpopexy support described in this application hasa head section connected to a leg section. The head section isattachable to the sacrum or to ligaments attached to the sacrum and theleg section is attached to walls of the vagina. The head section isstrong and suited for holding the vagina in its anatomically correctposition. The leg section is supple and suited for attachment to thesensitive tissues of the vagina. The head section is formed from amaterial that has more weight and more strength than the leg sectionmaterial. Embodiments described in this application provide a closedjoint structure within the leg section that is configured to isolate orseparate the heavier head section material away from the lighter weightleg section material that is attached to the sensitive vaginal tissues.Some advantages of the closed joint leg section structure include thereduction in the possibility of the heavier weight head section rubbingagainst the sensitive tissue of the vagina. A first option in providingthe leg section with a closed joint structure is to secure a first legportion to the head section with a first connector, and then fold anintegrated second leg portion over the first leg portion and then securethe second leg portion to the first leg portion and to the head sectionwith a second connector. Thus, the leg section has one connector throughthe first leg portion and the head section and a second connectorthrough second leg portion and the first leg portion and the headsection. The second connector closes off the space between the first andsecond leg portions and maintains the endmost part of the head sectionout from the closed space of the leg section. A second option inproviding the leg section with a closed joint structure is to secure afirst leg portion to the head section with a first connector, and thenfold an integrated second leg portion over the first leg portion andthen secure the second leg portion to the first leg portion with asecond connector. Thus, the leg section has one connector through thefirst leg portion and the head section and a second connector throughsecond leg portion and the first leg portion and not through the headsection. The second connector closes off the space between the first andsecond leg portions and maintains the endmost part of the head sectionbehind the second connector and away from the closed space of the legsection. A third option in providing the leg section with a closed jointstructure is to secure a first leg portion and a separate and individualsecond leg portion to the head section with a first connector, and thensecure the second leg portion to the first leg portion with a secondconnector. Thus, the leg section has one connector through the first legportion and the second leg portion and the head section and a secondconnector through second leg portion and the first leg portion and notthrough the head section. The second connector closes off the spacebetween the first and second leg portions and maintains the endmost partof the head section behind the second connector and away from the closedspace of the leg section. A fourth option in providing the leg sectionwith a closed joint structure is to secure a first leg portion on oneside and a separate and individual second leg portion to an oppositesecond side of the head section with a first connector, and then securethe second leg portion to the first leg portion with a second connector.The head section is located between the first leg portion and the secondleg portion. Thus, the leg section has one connector through the firstleg portion and the head section and the second leg portion, and asecond connector through second leg portion and the first leg portionand not through the head section. The second connector closes off thespace between the first and second leg portions and maintains theendmost part of the head section behind the second connector and awayfrom the closed space of the leg section. Regarding these options, thefirst leg portion can be the same length as the second leg portion, suchthat a middle portion of the leg section is located equidistant betweenthe first end and the second end of the leg section. Alternatively, thefirst leg portion can have a different length than the second legportion. The connectors may be a polymer thread that is stitched to thematerials, or an adhesive connection, or a thermal weld between polymermaterials.

One embodiment of a sacrocolpopexy support has a head section connectedto a leg section. The head section extends from a first end portion to asecond end portion. The leg section has a middle portion, a first legportion extending from the middle portion to a first end of the legsection, and a second leg portion extending from the middle portion to asecond end of the leg section. A fold is formed in the leg section suchthat the first leg portion is folded into contact with the second legportion. A first connector secures the head section to the first legportion and does not secure the head section to the second leg portion.A second connector secures the head section to the first leg portion andsecures the head section to the second leg section. In one embodiment,an end of the second end portion of the head section terminates at alocation between the second connector and an end of the first and secondleg portions.

Another embodiment of a sacrocolpopexy support has a head sectionextending from a first end portion to a second end portion, and a legsection having a middle portion, a first leg portion extending from themiddle portion to a first end of the leg section, and a second legportion extending from the middle portion to a second end of the legsection. A fold is formed in the leg section such that the first legportion is folded into contact with the second leg portion. A firstconnector connects the head section to the first leg portion, where thefirst connector is not coupled to the second leg portion. A secondconnector connects the first leg portion to the second leg portion,where the second connector is not coupled to the head section.

Another embodiment of a sacrocolpopexy support has a head sectionextending from a first end portion to a second end portion, and a legsection having a first leg portion placed on and in longitudinalalignment with a second leg portion. A first connector secures the legsection to the second end portion of the head section. The firstconnector secures at least one of the leg portions of the leg section tothe second end portion of the head section. A second connector securesthe first leg portion to the second leg portion. The second connector isnot coupled to the head section, and an end of the second end portion ofthe head section terminates at and is located between the firstconnector and the second connector.

Another embodiment of a sacrocolpopexy support has a head sectionextending from a first end portion to a second end portion and a legsection having a first leg portion placed on and in longitudinalalignment with a second leg portion. A first connector secures the legsection to the second end portion of the head section. A secondconnector secures the first leg portion to the second leg portion toform a closed joint that defines a space between the first leg portionand the second leg portion. An end of the second end portion of the headsection terminates at a location exterior to the closed joint outside ofthe space between the first leg portion and the second leg portion. Oneembodiment of this sacrocolpopexy support provides the leg section witha middle portion, with the first leg portion extending from the middleportion to a first end of the leg section and the second leg portionextending from the middle portion to a second end of the leg section; afold is formed in the middle portion of the leg section such that thefirst leg portion is folded into contact with the second leg portion;the first connector is connected through the first leg portion and thesecond end portion of the head section and not connected to the secondleg portion, and the second connector is connected through the first legportion, the second end portion of the head section, and the second legportion. One embodiment of this sacrocolpopexy support provides the legsection as a single integrated material with the first leg portionextending from and connected to the second leg portion, and a fold isformed in the leg section such that the first leg portion is folded intocontact with the second leg portion; the first connector is connectedthrough the first leg portion and the second end portion of the headsection and not connected to the second leg portion, and the secondconnector is not coupled to the head section; an end of the second endportion of the head section terminates at and is located between thefirst connector and the second connector. One embodiment of thissacrocolpopexy support provides the first leg portion as separate fromthe second leg portion, with the first leg portion longitudinallyaligned and in contact with the second leg portion; the first connectoris connected through the first leg portion, the second leg portion, andthe second end portion of the head section; the second connector is notcoupled to the head section; an end of the second end portion of thehead section terminates at and is located between the first connectorand the second connector. One embodiment of this sacrocolpopexy supportprovides the first leg portion as separate from the second leg portion,with the first leg portion longitudinally aligned with the second legportion and the second end portion of the head section is disposedbetween the first leg portion and the second leg portion; the firstconnector is connected through the first leg portion, the second endportion of the head section, and the second leg portion; the secondconnector is not coupled to the head section; an end of the second endportion of the head section terminates at and is located between thefirst connector and the second connector.

Another embodiment of a sacrocolpopexy support has a head sectionextending from a first end portion to a second end portion, and a legsection that is folded upon itself to provide a first leg portion and asecond leg portion. One or more connectors are employed to secure theleg section to the second end portion of the head section. In oneembodiment, three or more connectors are employed to secure the legsection to the head section.

The sacrocolpopexy support is Y-shaped, where the first leg portion andthe second leg portion combine to provide a V-shape and the head sectionis attached to the leg portions to form a combined Y-shape. When thesacrocolpopexy support is implanted, the head section is connected tothe sacrum or sacral tissue, and the V-shape of the leg section engagesthe vagina with the first leg portion connected to the anterior wall ofthe vagina and the second leg portion connected to the posterior wall ofthe vagina. The advantage provided by the configurations described inthis application is that the head section is spaced apart from and keptaway from contacting the sensitive tissue of the vagina. A connector isprovided to close the V-shape of the leg portions together in a way thatmaintains the end of the head section outside of the V-shape. The headsection connected to the sacrum is generally coarser, stronger, andtougher than the leg section. It is desirable to prevent the headsection from contacting the tissue of the vagina, as this couldpotentially lead to erosion of the vaginal tissue. The fold of the legsection, in combination with the first and second connector locations,ensures that only the softer leg section interacts with the delicatetissue of the vagina. In contrast, some supports have first leg attachedto a first side of the head section and a second leg attached to asecond side of the head section, which leaves the head section betweenthe legs and located to possibly abrade the delicate tissue of thevagina. Again, in contrast, some supports provide one long head section(or tail) that extends from the sacrum to the vagina and a shorter legsection is attached to the head section, which also locates the heavierand stiffer head section in contact with the vagina.

In one embodiment, the head section has an anterior side opposite of aposterior side, and the first leg portion and the second leg portion areboth located on only the anterior side of the head section. Thisconfiguration has the advantage of locating the leg section material forattachment to both sides of the vagina while also isolating the headsection material away from the tissue of the vagina.

In one embodiment, the leg section is a single integrated piece ofmaterial with the middle portion located equidistant between the firstend of the leg section and the second end of the leg section. Thisconfiguration has the advantage of providing the surgeon with asymmetrical leg section, so the surgeon does not have to spend timedeciding “which end is up.” The surgeon may, of course, choose to trimor cut the first and second leg portions to different lengths.

In one embodiment, the leg section is a rectangle defined by a legsection length and a leg section width, and the first connector and thesecond connector are connected to the second end portion of the headsection, with a width of the second end portion of the head section thatis equal to the leg section width and is larger than a width of thefirst end portion of the head section. This configuration has theadvantage of providing more width to the leg section, which aids thesurgeon in the attachment of the leg section to the wall of the vaginaand also provides excellent vaginal support. The narrower head sectionallows the surgeon to more easily pass the narrow end of the headsection under the peritoneum for connection to the sacrum.

In one embodiment, the first connector is closer to the fold than thesecond connector is to the fold. This configuration has the advantage oflocating the second connector farther from the fold compared to thefirst connector, which forms a vertex with leg section material on bothsides of the vertex. When the leg section is connected to the tissue ofthe vagina, the vertex locates leg section material on either side ofthe vagina and isolates the head section material away from the tissueof the vagina.

In one embodiment, the first connector is a suture that is stitchedthrough not more than two layers of material of the sacrocolpopexysupport. This configuration has the advantage of allowing the thirdlayer of material (the second leg portion) to fold over the firstconnector to provide a vertex of leg material that engages with thevagina, while also isolating the head section material away from thetissue of the vagina.

In one embodiment, the second connector is a suture that is stitchedthrough three layers of material of the sacrocolpopexy support. Thisconfiguration has the advantage of forming a vertex of leg material thatengages with the vagina, while also isolating the head section materialaway from the tissue of the vagina.

In one embodiment, a length of the first leg portion measured from thefold to the first end of the leg section is equal to a length of thesecond leg portion measured from the fold to the second end of the legsection. This configuration has the advantage of providing a symmetricleg portion.

In one embodiment, a distance measured from the second connector to thefirst end of the leg section is equal to a distance measured from thesecond connector to an end of the first end portion of the head section.This configuration has the advantage of providing a symmetric supportwith equal parts of a leg section attachable to the vagina and headsection.

In one embodiment, a transverse width of the leg section is greater thana transverse width of the first end portion of the head section. Thisconfiguration has the advantage of providing a smoothly tapered andnarrower head section.

In one embodiment, a basis weight of the leg section is less than 30g/m², which advantageously provides a light weight support structure forattachment to the delicate tissue of the vagina.

In one embodiment, a basis weight of the first leg portion is equal to abasis weight of the second leg portion, which advantageously provides auniform support structure for attachment to the delicate tissue of thevagina.

In one embodiment, a basis weight of the leg section is less than 30g/m² and a basis weight of the head section is greater than 30 g/m²,which advantageously provides a light weight support structure forattachment to the delicate tissue of the vagina and a heavier supportfor connection to the tough sacral tissue.

In one embodiment, a single line is printed in ink on the first legportion and is located longitudinally on a longitudinal center of thefirst leg portion to advantageously provide a guide or index that allowsthe surgeon to center the leg section relative to a wall of the vagina.

In one embodiment, a first line is printed in ink on the second legportion and a second line is printed in ink on the second leg portion,with each of the first line and the second line located longitudinallyon the second leg portion and offset away from a longitudinal center ofthe second leg portion. This configuration has the advantage ofdistinguishing the second leg portion from the first leg portion, whilealso providing the surgeon with a center location between the twoprinted lines.

Embodiments provide a sacrocolpopexy support having a head sectionconnected to a leg section. The head section extends from a first endportion to a second end portion. The leg section has a middle portion, afirst leg portion extending from the middle portion to a first end ofthe leg section, and a second leg portion extending from the middleportion to a second end of the leg section. A fold is formed in themiddle portion of the leg section, with the middle portion of the legsection connected to the head section. The head section has an anteriorside opposite of a posterior side, and in an embodiment both of thefirst leg portion and the second leg portion are located on only theanterior side of the head section.

Embodiments provide a sacrocolpopexy support having a leg sectionconnected to a head section. The head section is knitted with amonofilament polypropylene fiber into a knit structure having a weightper area in a range from 30-50 g/m². The leg section is knitted with amonofilament polypropylene fiber into a knit structure having a weightper area in a range from 17-29 g/m², with the leg section having a firstleg portion overlaying a second leg portion. A first connector connectsthe first leg portion to the second leg portion to form a closed spacelocated between the first leg portion and the second leg portion. Anentirety of the head section is located outside of the closed spacelocated between the first leg portion and the second leg portion.

In one embodiment, the head section is located on a proximal side of thesacrocolpopexy support and the leg section is located on a distal sideof the sacrocolpopexy support, and the entirety of the head section islocated proximal relative to the first connector. This configurationprovides the advantage of keeping the head section out of the closedspace located between the first leg portion and the second leg portion.When implanted, the vagina is located within the closed space locatedbetween the first leg portion and the second leg portion, and thus thehead section is isolated away from the sensitive tissues of the vagina.

FIG. 1 is a perspective view of one embodiment of a sacrocolpopexysupport 20 (support 20). The support 20 includes a head section 30connected to a leg section 40. The head section 30 is attached to thesacrum or its adjacent tissues during implantation and the leg section40 is attached to an exterior wall of the vagina. The head section 30 issuitably attached to the bony sacrum or the soft tissues covering thebony sacrum or the connective tissues, such as ligaments, extending fromthe sacrum. Sutures, staples, or tacks, depending upon the preference ofthe surgeon, may be employed to secure the head section 30 to the sacraltissue. The leg section 40 is generally secured to an exterior surfaceof both the anterior wall and the posterior wall of the vagina, forexample through the use of sutures.

The head section 30 has a first end portion 32 terminating in a firstend 34 and a second end portion 36 terminating in a second end 38.

The leg section 40 has a middle portion 42, a first leg portion 44extending from the middle portion 42 to a first end 46, and a second legportion 54 extending from the middle portion 42 to a second end 56. Thefirst leg portion 44 and the second leg portion 54 are connected to thehead section 30.

A portion of the leg section 40 is connected to the head section 30, anda fold 60 is formed in the leg section 40 to place the second legportion 54 over the first leg portion 44. The leg section 40 is a singleintegrated piece of material with the middle portion 42 located betweenthe first end 46 and the second end 56 of the leg section 40. The fold60 can be folded in a manual procedure by hand, or in an automatedprocedure by machine prior to securing the leg section 40 to the headsection 30, or after first securing a part of the leg section 40 to partof the head section 30. In one embodiment, the first leg portion 44 isthe same length as the second leg portion 54, such that the middleportion 42 is located equidistant between the first end 46 and thesecond end 56 of the leg section 40. In one embodiment, the first legportion 44 has a different length than the second leg portion 54.

A first connector 70 secures the head section 30 to the first legportion 44, and a second connector 80 secures the head section 30 to thefirst leg portion 44 and the second leg portion 54. Suitable connectorsfor the first connector 70 and the second connector 80 include a polymerstrand that is stitched through portions of the support 20,ultrasonically welded lines, segments of glue, or combinations of glueand sutures. In one embodiment, the first connector 70 and the secondconnector 80 are provided by a polypropylene monofilament strand that isstitched through portions of the head section 30 and the leg section 40.

The support 20 is selected to be bio-compatible with implantation into ahuman body and is configured to allow tissue to grow through the headsection 30 and the leg section 40 to anchor the support 20 in the bodyafter implantation and healing. Suitable materials for the support 20include autograft material (the patient's own tissue), allograftmaterial (tissue from a cadaver), xenograft material (tissue fromanother species), or synthetic materials such as knitted meshes, wovenfabrics or meshes, nonwoven fabrics or meshes, fibrillated fibers, orspun and fibrillated fibers. The support 20 is provided with voidsincluding major spaces and smaller pores. The voids allow tissueingrowth into and through the support 20. The major spaces have a sizein a range from 1-10 mm and the pores have a size in a range from 50-200μm.

In one embodiment, the support 20 is a knitted monofilamentpolypropylene mesh with the head section 30 provided with a heavierweight per area than the leg section 40.

One suitable head section 30 is knitted with a 100 μm monofilamentpolypropylene fiber into a knit structure having a thickness in a rangefrom 0.3-0.5 mm and a weight per area in a range from 30-50 g/m², andpreferably with a weight per area of approximately 34 g/m². Other fibersformed from other material and having a diameter different from the 100μm monofilament polypropylene fiber are also acceptable. For example,fiber having a 90 μm or a 120 μm diameter is acceptable.

One suitable leg section 40 is knitted with an 80 μm monofilamentpolypropylene fiber into a knit structure having a thickness in a rangefrom 0.25-0.36 mm and a weight per area in a range from 17-29 g/m², andpreferably with a weight per area of approximately 22 g/m². Other fibersformed from other material and having a diameter different from the 80μm monofilament polypropylene fiber are also acceptable. For example,fiber having a 70 μm or a 90 μm diameter is acceptable. In oneembodiment, the leg section 40 is provided as a rectangle that is foldedon a line about fold 60 such that the weight per area of the first legportion 44 is equal to the weight per area of the second leg portion 54.

The leg section 40 mesh is thin and light weight (i.e., the weight perarea or basis weight is less than approximately 30 g/m²) to provide athin and comfortable mesh that is agreeable with the delicate vaginaltissue that contacts the mesh and is less likely to be sensed throughthe tissue layers by the patient.

The embodiments of the support provide a structure that keeps theheavier material of the head section 30 separated away from thesensitive tissue of the vagina. This is achieved by locating the heavierweight material of the head section 30 away from where the light weightmaterial of the leg section 40 is attached (or attachable) to thevagina.

Suitable knitted monofilament polypropylene mesh is available fromColoplast Corp., Minneapolis, Minn.

FIG. 2 is a right side view of the support 20 and FIG. 3 is a view ofthe connectors 70, 80 securing the head section 30 to the leg section40.

The fold 60 is formed in the middle portion 42 of the leg section 40.The first connector 70 secures the head section 30 to the first legportion 44 but does not secure the head section 30 to the second legportion 54. That is to say, the first connector 70 extends through thehead section 30 and only the first leg portion 44 and does not extendthrough the second leg portion 54. The first connector 70 is coupled tothe head section 30 and only the first leg portion 44 and is not coupledto the second leg portion 54. The second connector 80 secures the headsection 30 to both the first leg portion 44 and the second leg portion54.

The leg section 40 and the head section 30 combine to provide a Y-shapedsupport when viewed from a side edge of the sacrocolpopexy support 20,as illustrated in FIGS. 1-3 . The Y-shaped support 20 has a V-shapedportion formed by the first leg portion 44 and the second leg portion,and the head section 30 is attached to the V-shaped portion to completethe Y-shaped conformation. When implanted, the V-shape of the legsection 40 engages the vagina with the first leg portion 44 connected tothe anterior wall of the vagina and the second leg portion 54 connectedto the posterior wall of the vagina. The head section 30 is spaced apartfrom and kept out of the interior of the V-shaped portion of the legsection 40. Specifically, the second connector 80 has closed theV-shaped portion at its apex area. This configuration ensures that thehead section 30 is kept away from contacting the sensitive tissue of thevagina since the head section 30 is maintained outside of the V-shapedportion of the leg section 40.

In one embodiment, the connector 80 connects the first leg portion 44 tothe second leg portion 54 to form a closed space 82 located between thefirst leg portion 44 and the second leg portion 54, and an entirety ofthe head section 30 is located outside of the closed space 82 locatedbetween the first leg portion 44 and the second leg portion 54.

In one embodiment, the head section 30 has an anterior side 90 oppositeof a posterior side 92, and the connectors 70, 80 secure the folded legsection 40 to only one of the anterior side 90 or the posterior side 92of the head section 30. In the exemplary embodiment illustrated in FIGS.2 and 3 , the first leg portion 44 and the second leg portion 54 areboth located on only the anterior side 90 of the head section 30.

With regard to the attachment, the first connector 70 is coupled to notmore than two layers of material of the support 20 and second connector80 is coupled to at least three layers (head section 30 and both legportions 44, 54) of material of the support 20. For example, the firstconnector 70 is a suture that is stitched through not more than twolayers of material of the support 20 and the second connector 80 is asuture that is stitched through three layers, or more than three layers,of material of the support 20. One suitable connector material ispolypropylene monofilament, for example, an 80 μm monofilamentpolypropylene fiber. In one embodiment, the first connector 70 isseparate and distinct from the second connector 80. In one embodiment,the first connector 70 and the second connector 80 are formed by a sewnpattern that provides both connectors 70, 80 where the first connector70 extends through the head section 30 and only the first leg portion 44and does not extend through the second leg portion 54 and the secondconnector 80 secures the head section 30 to both the first leg portion44 and the second leg portion 54. In one embodiment, each of theconnectors 70, 80 is formed by an interlocking stitch that is stitchedacross the full width of the head section 30 and the leg section 40. Theinterlocking stitch is placed in a transverse direction, preferablyparallel with the second end 38 of the head section 30.

The first connector 70 and the second connector 80 fixate the middleportion 42 of the leg section 40 to the second end portion 36 of thehead section 30. The first connector 70 is closer to the fold 60 thanthe second connector 80 is to the fold 60, which is to say that thesecond connector 80 is closer to the second end 38 of the head section30 than the first connector 70 is to the second end 38 of the headsection 30. In one embodiment, a length of the first leg portion 44measured from the fold 60 to the first end 46 is equal to a length ofthe second leg portion 54 measured from the fold 60 to the second end 56of the leg section 40.

It is acceptable to secure the leg section 40 to the head section 30 by,for example, securing first leg portion 44 to the head section 30 withadhesive or by thermal welding of the materials, and then to place asingle mechanical connector, such as stitch line 80 or adhesive orthermal welding, to secure the first leg portion 44 to the second legportion 54, where the single connector closes the leg section 40 andisolates the end 38 of the head section 30 outside of the closed spaceformed between the leg portions 44, 54.

FIG. 4A and FIG. 4B are a top perspective views and FIG. 4C is a sideschematic view of the first connector 70 and the second connector 80securing the head section 30 to the leg section 40.

The first connector 70 and the second connector 80 combine to providewhat is termed a closed joint construction that separates the vaginalattachment portions of the lightweight structure of the leg section 40away from the heavier structure of the head section 30. The closed jointconstruction is provided by aligning the open pores or open holes of thefirst leg portion 44 with the open holes of the head section 30 and thenstitching a monofilament fiber through the open holes of the first legportion 44 and the head section 30 to provide the first connector, whichis illustrated by the dotted line 70 since this stitch pattern would becovered over by the second leg portion 54 (and thus not visible fromabove). A separate second stitch, spaced apart from the first stitch ofconnector 70, is passed through the aligned open holes of the first legportion 44, the second leg portion 54, and the head section 30 toprovide the second connector 80, which is illustrated by the solid line80 since this stitch goes through all three layers and is visible fromabove and below.

The stitches of the first and second connectors 70, 80 are formed in apath along a width of the support 20 in the aligned holes of the legsection 40 and the head section 30. In one embodiment, each stitch isformed in two passes, first in one direction across a width the support20 and then in a reversed, second path across the width support 20. Theadvantage of a two-pass stitch pattern is realized in thattwice-stitched closed joint resists separation when the support 20 istrimmed or cut. The two-pass stitch pattern forms a strong joint thatallows the surgeon to cut the support 20 without the undesirableconsequence of the leg section 40 separating from the head section 30.

In the illustrated embodiment, the head section 30 has an anterior side90 opposite of a posterior side 92, and the first leg portion 44 and thesecond leg portion 54 are both located on only the anterior side 90 ofthe head section 30. This configuration contributes to the keeping theheavier structure of the head section 30 away from the sensitive tissueof the vagina that is supported by and attached to the lightweightstructure of the leg section 40.

FIG. 5 is a front view of the support 20 and FIG. 6 is a back view ofthe support 20. FIG. 5 is thus a view of the second leg portion 54 andFIG. 6 is a view of the first leg portion 44.

The leg section 40 has a leg section length L and a leg section width WL(thus, the first leg portion 44 and the second leg portion 54 each havea length of L/2). The leg section 40 is folded at the fold 60 (See FIG.3 ). The first connector 70 and the second connector 80 are connected tothe second end portion 36 of the head section 30. A width WH2 of thesecond end portion 36 of the head section 30 is equal to the leg sectionwidth WL and is larger than a width WH1 of the first end portion 32 ofthe head section 30. In this manner, the head section 30 diverges from anarrower width WH1 at the first end 34 to a wider width WH2 at thesecond end section 36, and the width WH2 is equal to the width WL of theleg section 40. Thus, a transverse width of the leg section 40 (WL) isgreater than a transverse width of the first end portion 32 of the headsection 30 (WH1).

In one embodiment, the support 20 is configured such that a distance S/2measured from the second connector 80 to the first end 46 of the legsection 40 is equal to a distance S/2 measured from the second connector80 to the end 34 of the head section 30. The total length of the support20 is S (S/2 plus S/2).

In one embodiment, the support 20 has a single line 94 printed in ink onthe second leg portion 54, with the single line 94 locatedlongitudinally on a longitudinal center LC of the second leg portion 54.

In one embodiment, the support 20 has dual lines printed on the firstleg portion. For example, a first line 96 is printed in ink on the firstleg portion 44 and a second line 98 is printed in ink on the first legportion 44, with each of the first line 96 and the second line 98located longitudinally on the first leg portion 44 and offset away fromthe longitudinal center LC of the support 20 and the first leg portion44.

The printed lines provide a guide to allow the surgeon to place the legsection 40 in a desired orientation. The printed lines are an optionalfeature for the support 20.

FIG. 7 is a schematic perspective view of the sacrocolpopexy support 20implanted in a patient.

One acceptable procedure for implanting the support 20 into the patientis a trans-abdominal laparoscopic procedure. Some healthcare facilitiesemploy robotically assisted laparoscopic procedures. During thetrans-abdominal laparoscopic procedure, access ports (trocars) areplaced in the abdomen of the patient. The laparoscope is insertedthrough one of the trocars into the abdomen for access to the vaginalcuff. An inert gas is pumped into a second of the trocars to inflate theabdominal region for improved access and viewing of the pelvic organs.The surgeon will often position the vagina by inserting a supportingdevice (sometimes referred to as a manipulator) into the natural vaginalopening to orient the vaginal cuff to a desired position suited forviewing of the vaginal cuff when attaching the support 20. Othersurgical procedures are also acceptable, depending upon surgeonpreference.

The support 20 is inserted through a trocar. The head section 30 issecured to the sacrum and the leg section 40 is secured to the vaginalcuff. In the illustration of FIG. 7 , the second leg portion 54 has beenattached to the anterior wall of the vagina and the first leg portion 44has been attached to the posterior wall of the vagina. It is alsoacceptable to attach the head section 30 the sacrospinous ligament,depending upon the preference of the surgeon.

FIG. 8 is a schematic side view of the sacrocolpopexy support 20 securedto a vagina of a patient. The head section 30 extends superiorly to thewhere it is attached to the sacrum and the leg section 40 extendsinferiorly where it is attached to the cuff of the vagina. The first legportion 44 has been secured to the posterior wall of the vagina and thesecond leg portion 54 has been secured to the anterior wall of thevagina. Suitable securement devices such as sutures or staples areemployed for fixation, depending upon the preference of the surgeon. Thefold 60 in combination with the connectors 70, 80 and their locationscombine to ensure that lighter weight material of the leg portions 44,54 are the only portion of the support 20 that is in contact with thedelicate tissue of the vagina. The head section 30, fabricated from aheavier material than the leg section, is isolated and separated awayfrom the delicate tissue of the vagina.

Exemplary Performance Data

Sacrocolpopexy supports were fabricated and evaluated. The supports eachhave a head section and a leg section, and Table 1 below illustrates thephysical properties of each of these portions of the support. Thephysical properties recited in Table 1 provide one example ofperformance characteristics for use as a sacrocolpopexy support in thetreatment of pelvic organ prolapse.

TABLE 1 Property Head Section Leg Section Suture pull ≥11.6N  ≥8.7NTensile strength 2 cm width ≥33.8N ≥20.9N Tear strength  ≥6.2N  ≥4.3NBending length 2 cm width ≤36.5 mm ≤36.5 mm Density 30-34.0 g/m² ≤22.62g/m² Thickness 0.013-0.019 in 0.011-0.014 in Ball burst strength ≥28.0N≥13.1N Large pore length 1.8-2.2 mm 1.8-2.2 mm Small pore dimension ≥75μm ≥75 μm

FIG. 9 is a perspective view of another embodiment of a sacrocolpopexysupport 120 (support 120).

The support 120 includes a head section 130 connected to a leg section140. The head section 130 is attached to the sacrum or its adjacenttissues during implantation and the leg section 140 is attached to anexterior wall of the vagina. The head section 130 is suitably attachedto the bony sacrum or the soft tissues covering the bony sacrum or theconnective tissues, such as ligaments, extending from the sacrum.Sutures, staples, or tacks, depending upon the preference of thesurgeon, may be employed to secure the head section 130 to the sacraltissue. The leg section 140 is generally secured to an exterior surfaceof both the anterior wall and the posterior wall of the vagina, forexample through the use of sutures.

FIG. 10 is a right side view and FIGS. 11A and 11B are perspective viewsof the support 120.

The head section 130 has a first end portion 132 terminating in a firstend 134 and a second end portion 136 terminating in a second end 138.

The leg section 140 has a middle portion 142, a first leg portion 144extending from the middle portion 142 to a first end 146, and a secondleg portion 154 extending from the middle portion 142 to a second end156.

A first connector 170 secures the head section 130 to the first legportion 144, and a second connector 180 secures the first leg portion144 to the second leg portion 154 and is not coupled through the headsection 130. Suitable connectors for the first connector 170 and thesecond connector 180 include a polymer strand that is stitched throughportions of the support 120, ultrasonically welded lines, segments ofglue, or combinations of glue and sutures. In one embodiment, the firstconnector 170 and the second connector 180 are provided by an 80 μmmonofilament polypropylene fiber.

This embodiment of a sacrocolpopexy support 120 has a head section 130extending from a first end portion 132 to a second end portion 136, anda leg section 140 having a first leg portion 144 placed on and inalignment with a second leg portion 154. A first connector 170 securesthe leg section 140 to the second end portion 136 of the head section130. A second connector 180 secures the first leg 144 portion to thesecond leg portion 154. The second connector 180 is not coupled to thehead section 130, and an end 138 of the second end portion 136 of thehead section 130 terminates at and is located between the firstconnector 170 and the second connector 180.

In one embodiment, a fold 160 is formed in the leg section 140 such thatthe first leg portion 144 is folded into contact with the second legportion 154. The leg section 140 is a single integrated piece ofmaterial with the middle portion 142 located between the first end 146and the second end 156 of the leg section 140. In one embodiment, theleg section 140 is provided as a rectangle that is folded on a lineabout fold 160 such that the weight per area of the first leg portion144 is equal to the weight per area of the second leg portion 154. Thefold 160 can be folded in a manual procedure by hand or in an automatedprocedure by machine prior to securing the leg section 140 to the headsection 130. In an exemplary embodiment, the first connector 170 isplaced to secure the first leg portion 144 to the head section 130, andthe second leg portion 154 is folded to overlay the first leg portion144 prior to securing the first leg portion 144 to the second legportion 154 with the connector 180.

In one embodiment, the first leg portion 144 is placed on top of thesecond leg portion 154 and these components are not folded as anintegral piece of material.

It is acceptable to secure the leg section 140 to the head section 130by, for example, securing first leg portion 144 to the head section 130with adhesive or by thermal welding of the materials, and then to placea single mechanical connector, such as stitch line 180 or adhesive orthermal welding, to secure the first leg portion 144 to the second legportion 154, where the single connector closes the leg section 140 andisolates the end 138 of the head section 130 outside of the closed spaceformed between the leg portions 144, 154.

In one embodiment, the first leg portion 144 is the same length as thesecond leg portion 154, such that the middle portion 142 is locatedequidistant between the first end 146 and the second end 156 of the legsection 140. In one embodiment, the first leg portion 144 has adifferent length than the second leg portion 154.

The support 120 is selected to be bio-compatible with implantation intoa human body and is configured to allow tissue to grow through the headsection 130 and the leg section 140 to anchor the support 120 in thebody after implantation and healing. Suitable materials for the support120 include autograft material (the patient's own tissue), allograftmaterial (tissue from a cadaver), xenograft material (tissue fromanother species), or synthetic materials such as knitted meshes, wovenfabrics or meshes, nonwoven fabrics or meshes, fibrillated fibers, orspun and fibrillated fibers. The support 120 is provided with voidsincluding major spaces and smaller pores. The voids allow tissueingrowth into and through the support 120. The major spaces have a sizein a range from 1-10 mm and the pores have a size in a range from 50-200μm.

In one embodiment, the support 120 is a knitted monofilamentpolypropylene mesh with the head section 130 provided with a heavierweight per area than the leg section 140.

One suitable head section 130 is knitted with a 100 μm monofilamentpolypropylene fiber into a knit structure having a thickness in a rangefrom 0.3-0.5 mm and a weight per area in a range from 30-50 g/m², andpreferably with a weight per area of approximately 34 g/m².

One suitable leg section 140 is knitted with an 80 μm monofilamentpolypropylene fiber into a knit structure having a thickness in a rangefrom 0.25-0.36 mm and a weight per area in a range from 17-29 g/m², andpreferably with a weight per area of approximately 22 g/m².

The leg section 140 material is thin and light weight (i.e., the weightper area or basis weight is less than approximately 30 g/m²) to providea thin and comfortable mesh that is agreeable with the delicate vaginaltissue that contacts the mesh and is less likely to be sensed throughthe tissue layers by the patient.

The embodiments of the support provide a structure that keeps theheavier material of the head section 130 separated away from thesensitive tissue of the vagina. This is achieved by locating the heavierweight material of the head section 130 away from where the light weightmaterial of the leg section 140 is attached (or attachable) to thevagina. Specifically, the end 138 of the second end portion 136 of thehead section 130 terminates at and is located between the firstconnector 170 and the second connector 180.

Suitable knitted monofilament polypropylene mesh is available fromColoplast Corp., Minneapolis, Minn.

The first connector 170 secures the head section 130 to the first legportion 144 but does not secure the head section 130 to the second legportion 154. That is to say, the first connector 170 extends through thehead section 130 and only the first leg portion 144 and does not extendthrough the second leg portion 154. The first connector 170 is coupledto the head section 130 and only the first leg portion 144 and is notcoupled to the second leg portion 154. The second connector 180 iscoupled between the first leg portion 144 and the second leg portion154, and is not coupled to the head section 130.

The leg section 140 and the head section 130 combine to provide aY-shaped support when viewed from a side edge of the sacrocolpopexysupport 120.

In one embodiment, the head section 130 has an anterior side 190opposite of a posterior side 192, and the connector 170 secures the legsection 140 to only one of the anterior side 190 or the posterior side192 of the head section 130.

The first connector 170 is coupled to not more than two layers ofmaterial of the support 120 and second connector 180 is coupled to notmore than two layers (e.g., only the leg portions 144, 154) of materialof the support 120. For example, the first connector 170 is a suturethat is stitched through not more than two layers of material of thesupport 120 and the second connector 180 is a suture that is stitchedonly the leg portions 144, 154 of the support 120 and not through thehead section 130. One suitable connector material is polypropylenemonofilament, for example, an 80 μm monofilament polypropylene fiber. Inone embodiment, the first connector 170 is separate and distinct fromthe second connector 180. In one embodiment, each of the connectors 170,180 is formed by an interlocking stitch that is stitched across the fullwidth of the support 120. The interlocking stitch is placed in atransverse direction, preferably parallel with the second end 138 of thehead section 130.

The first connector 170 attaches the leg section 140 to the second endportion 136 of the head section 130. In one embodiment, the second end138 of the head section 130 is located equidistantly between theconnectors 170, 180. In one embodiment, the end 130 of the head section130 is located closer to the first connector 170 that it is to thesecond connector 180, which additionally serves to separate the end 138away from the light weight material of the leg section 140 that isultimately attached to the vaginal tissue.

In one embodiment, the connector 180 connects the first leg portion 144to the second leg portion 154 to form a closed space located between thefirst leg portion 144 and the second leg portion 154, and an entirety ofthe head section 130 is located outside of the closed space locatedbetween the first leg portion 144 and the second leg portion 154.

FIG. 12 is a side schematic view of the first connector 170 and thesecond connector 180 locations.

The first connector 170 and the second connector 180 combine to providewhat is termed a closed joint construction that separates the vaginalattachment portions of the lightweight structure of the leg section 140away from the heavier structure of the head section 130. The closedjoint construction is provided by aligning the open pores or open holesof the first leg portion 144 with the open holes of the head section 130and then stitching a monofilament fiber through the open holes of thefirst leg portion 144 and the head section 130 to provide the firstconnector 170. The first connector 170 passes through only two layers,namely one leg portion 144 and the head section 130. A separate secondstitch 180, spaced apart from the first connector 170, is passed throughthe aligned open holes of the first leg portion 144 and the second legportion 154. The second connector passes through only the two layers ofthe leg portions 144, 154 and not through the head section 130.

In one embodiment, each stitch is formed in two passes, first in onedirection across a width the support 120 and then in a reversed, secondpath across the width support 120. The advantage of a two-pass stitchpattern is realized in that twice-stitched closed joint resistsseparation when the support 120 is trimmed or cut. The two-pass stitchpattern forms a strong joint that allows the surgeon to cut the support120 without the undesirable consequence of the leg section 140separating from the head section 130.

In the illustrated embodiment, the head section 130 has an anterior side190 opposite of a posterior side 192, and the first leg portion 144 andthe second leg portion 154 are both located on only the anterior side190 of the head section 130. This configuration contributes to thekeeping the heavier structure of the head section 130 away from thesensitive tissue of the vagina that is supported by and attached to thelightweight structure of the leg section 140.

FIG. 13 is a front view of the support 120 and FIG. 14 is a back view ofthe support 120. FIG. 13 is thus a top view of the second leg portion154 and FIG. 14 is a view of the first leg portion 144.

The leg section 140 has a leg section length L and a leg section widthWL (thus, the first leg portion 144 and the second leg portion 154 eachhave a length of L/2). The first connector 170 is connected to thesecond end portion 136 of the head section 130. A width WH2 of thesecond end portion 136 of the head section 130 is equal to the legsection width WL and is larger than a width WH1 of the first end portion132 of the head section 130. In this manner, the head section 130diverges from a narrower width WH1 at the first end 134 to a wider widthWH2 at the second end section 136, and the width WH2 is equal to thewidth WL of the leg section 140. Thus, a transverse width of the legsection 140 (WL) is greater than a transverse width of the first endportion 132 of the head section 130 (WH1).

The support 120 is configured such that a distance S/2 measured from thesecond connector 180 to the first end 146 of the leg section 140 isequal to a distance S/2 measured from the second connector 180 to theend 134 of the head section 130. The total length of the support 120 isS (S/2 plus S/2).

In one embodiment, the support 120 has a single line 194 printed in inkon the second leg portion 154, with the single line 194 locatedlongitudinally on a longitudinal center LC of the second leg portion154.

In one embodiment, the support 120 has dual lines printed on the firstleg portion 144. For example, a first line 196 is printed in ink on thefirst leg portion 144 and a second line 198 is printed in ink on thefirst leg portion 144, with each of the first line 196 and the secondline 198 located longitudinally on the first leg portion 144 and offsetaway from the longitudinal center LC of the support 120 and the firstleg portion 144.

The printed lines provide a guide to allow the surgeon to place the legsection 140 in a desired orientation. The printed lines are an optionalfeature for the support 120.

FIG. 15 is a schematic side view of the sacrocolpopexy support 120secured to a vagina of a patient. The head section 130 extends superiorto the where it is attached to the sacrum and the leg section 140extends inferior where it is attached to the cuff of the vagina. Thefirst leg portion 144 has been secured to the posterior wall of thevagina and the second leg portion 154 has been secured to the anteriorwall of the vagina. Suitable securement devices such as sutures orstaples are employed for fixation, depending upon the preference of thesurgeon. The lighter weight material of the leg portions 144, 154 arethe only portion of the support 120 that is in contact with the delicatetissue of the vagina. The head section 130, fabricated from a heaviermaterial than the leg section 140, is isolated and separated away fromthe delicate tissue of the vagina by locating the end 138 of the headsection 130 between the second connector 180 and the first connector170. The second connector 180 passes through and couples the legportions 144, 154 together to form the closed joint, and this ensuresthat the heavier weight head section 130 is separated away from theattachment location of the leg section 140 to the vagina, and thus onlythe light weight and comfortable material of the leg section 140 is incontact with the sensitive tissue of the vagina.

FIG. 16 is a schematic side view of one embodiment of a sacrocolpopexysupport 220.

The support 220 has a head section 230 extending between a first end 234and a second end 238 and a leg section 240. The leg section 240 has afirst leg portion 244 extending between ends 246 and 247, and a secondleg portion 254 extending between ends 256 and 257. The leg portions244, 254 are aligned one on top of the other and secured by a firstconnector 270 and a second connector 280. The first connector 270 passesthrough and couples the leg portions 244, 254 to the head section 230.The second connector 280 passes through and couples the leg portions244, 254. The second connector 280 is not coupled to the head section230 and operates to close off the head section 230 and separate the headsection 230 from the sensitive tissues of the vagina. In one embodiment,the second end 238 of the head section 230 is located between the firstand second connectors 270, 280 to isolate and separate the head section230 from the location where the leg section 240 is attached to thesensitive vaginal tissue.

In one embodiment, the second end 238 of the head section 230 is locatedon one side of the leg section 240, for example on the side of the firstleg portion 244 opposite from the second leg portion 254, and the secondconnector 280 is placed to close off the possibility of the head section230 from touching or abrading the sensitive vaginal tissue.

In one embodiment, the support 220 is a knitted monofilamentpolypropylene mesh with the head section 230 provided with a heavierweight per area than the leg section 240.

One suitable head section 230 is knitted with a 100 μm monofilamentpolypropylene fiber into a knit structure having a thickness in a rangefrom 0.3-0.5 mm and a weight per area in a range from 30-50 g/m², andpreferably with a weight per area of approximately 34 g/m².

One suitable leg section 140 is knitted with an 80 μm monofilamentpolypropylene fiber into a knit structure having a thickness in a rangefrom 0.25-0.36 mm and a weight per area in a range from 17-29 g/m², andpreferably with a weight per area of approximately 22 g/m².

The leg section 240 material is thin and light weight (i.e., the weightper area or basis weight is less than approximately 30 g/m²) to providea thin and comfortable mesh that is agreeable with the delicate vaginaltissue that contacts the mesh and is less likely to be sensed throughthe tissue layers by the patient.

The support 220 provides a structure that keeps the heavier material ofthe head section 230 separated away from the sensitive tissue of thevagina. This is achieved by locating the heavier weight material of thehead section 230 away from where the light weight material of the legsection 240 is attached (or attachable) to the vagina. Specifically, theend 238 of the head section 230 terminates at and is located between thefirst connector 270 and the second connector 280, which ensures that theheavier head section is not able to contact the walls or tissue of thevagina.

It is acceptable to secure the leg section 240 to the head section 230by, for example, securing first leg portion 244 to the head section 230with adhesive or by thermal welding of the materials, and then to placea single mechanical connector, such as stitch line 280 or adhesive orthermal welding, to secure the first leg portion 244 to the second legportion 254, where the single connector closes the leg section 240 andisolates the end 238 of the head section 230 outside of the closed spaceformed between the leg portions 244, 254.

FIG. 17 is a schematic side view of one embodiment of a sacrocolpopexysupport 320.

The support 320 has a head section 330 terminating at an end 338 and aleg section 340. The leg section 340 has a first leg portion 344 and asecond leg portion 354. The leg portions 344, 354 are aligned one on topof the other and secured by a first connector 370 and a second connector380. The first connector 370 passes through and couples the leg portions344, 354 to the head section 330. The second connector 380 closes theleg portions 344, 354 and isolates the end 338 of the head section 330outside of the V-shape formed by the leg portions 344, 354. The secondconnector 380 is not coupled to the head section 330 and operates toseparate the head section 330 away from the area where the V-shape ofthe leg section 340 engages with the sensitive tissues of the vagina. Inone embodiment, the end 338 of the head section 330 is located betweenthe first and second connectors 370, 380 to isolate and separate thehead section 330 from the location where the leg section 340 is attachedto the sensitive vaginal tissue.

In one embodiment, the second end 338 of the head section 330 islocated, or sandwiched, between the first and second leg portions 344,354 and the second connector 380 is placed to close the head section 330from entering the V-shape of the leg section 340 that engages with thesensitive tissues of the vagina.

It is acceptable to secure the leg section 340 to the head section 330by, for example, securing first leg portion 344 to the head section 330with adhesive or by thermal welding of the materials, and then to placea single mechanical connector, such as stitch line 380 or adhesive orthermal welding, to secure the first leg portion 344 to the second legportion 354, where the single connector closes the leg section 340 andisolates the end 338 of the head section 330 outside of the closed spaceformed between the leg portions 344, 354.

Embodiments include the following examples.

Example 1 is a sacrocolpopexy support comprising:

a head section extending from a first end portion to a second endportion;

a leg section having a middle portion, a first leg portion extendingfrom the middle portion to a first end of the leg section, and a secondleg portion extending from the middle portion to a second end of the legsection;

a fold formed in the leg section such that the first leg portion isfolded into contact with the second leg portion;

a first connector securing the head section to the first leg portion andnot securing the head section to the second leg portion; and

a second connector securing the head section to the first leg portionand securing the head section to the second leg section.

Example 2 adds to Example 1, where the head section has an anterior sideopposite of a posterior side, and the first leg portion and the secondleg portion are both located on only the anterior side of the headsection.

Example 3 adds to Example 1, where the leg section is a singleintegrated piece of material with the middle portion located equidistantbetween the first end of the leg section and the second end of the legsection.

Example 4 adds to Example 1, the leg section has a leg section width,and the first connector and the second connector are connected to thesecond end portion of the head section; and a width of the second endportion of the head section is equal to the leg section width and islarger than a width of the first end portion of the head section.

Example 5 adds to Example 1, where the first connector is closer to thefold than the second connector is to the fold.

Example 6 adds to Example 1, where the first connector is a suture thatis stitched through not more than two layers of material of thesacrocolpopexy support.

Example 7 adds to Example 1, where the second connector is a suture thatis stitched through three layers of material of the sacrocolpopexysupport.

Example 8 adds to Example 1, a length of the first leg portion measuredfrom the fold to the first end of the leg section is equal to a lengthof the second leg portion measured from the fold to the second end ofthe leg section.

Example 9 adds to Example 1, where a distance measured from the secondconnector to the first end of the leg section is equal to a distancemeasured from the second connector to an end of the first end portion ofthe head section.

Example 10 adds to Example 1, where a transverse width of the legsection is greater than a transverse width of the first end portion ofthe head section.

Example 11 adds to Example 1, where a basis weight of the leg section isless than 30 g/m².

Example 12 adds to Example 1, where a basis weight of the first legportion is equal to a basis weight of the second leg portion.

Example 13 adds to Example 1, where a basis weight of the leg section isless than 30 g/m² and a basis weight of the head section is greater than30 g/m².

Example 14 adds to Example 1, where a single line is printed in ink onthe second leg portion and located longitudinally on a longitudinalcenter of the second leg portion.

Example 15 adds to Example 1, where a first line is printed in ink onthe first leg portion and a second line printed in ink on the first legportion, with each of the first line and the second line locatedlongitudinally on the first leg portion and offset away from alongitudinal center of the first leg portion.

Although specific embodiments have been illustrated and described inthis disclosure, it will be appreciated by those of ordinary skill inthe art that a variety of alternate and/or equivalent implementationsmay be substituted for the specific embodiments shown and describedwithout departing from the scope of this disclosure. This application isintended to cover any adaptations or variations of the above-disclosedmedical devices. Therefore, it is intended that this invention islimited only by the claims and their equivalents.

What is claimed is:
 1. A method of treating prolapse of a vagina, themethod comprising: obtaining a sacrocolpopexy support, saidsacrocolpopexy support comprising a head section having a first end anda second end; a vaginal cuff section, the vaginal cuff section having afirst leg portion coupled to a second leg portion to define a spacebetween the first leg portion and the second leg portion, and aconnector directly secured to the first leg portion, the second legportion, and the second end of the head section, wherein the connectoris configured to isolate the second end of the head section outside ofthe space between the first leg portion and the second leg portion;supporting the vagina by implanting the sacrocolpopexy support andfixating an exterior surface of the vagina within the space between thefirst leg portion and the second leg portion of the vaginal cuffsection; securing the first end of the head section of thesacrocolpopexy support to one of a ligament and a sacrum; and isolatingthe second end of the head section of the sacrocolpopexy support fromcontact with tissue of the vagina by having the second end of the headsection exterior the space between the first leg portion and the secondleg portion.
 2. The method of claim 1, wherein the sacrocolpopexysupport comprises a second connector, with the connector secured to thefirst leg portion, the second leg portion, and the head section; andwherein isolating the second end of the head section of thesacrocolpopexy support from contact with tissue of the vagina comprisesnot coupling the second connector to the head section thereby separatingthe second end of the head section from sensitive tissue of the vagina.3. The method of claim 1, wherein the vaginal cuff section comprises asingle integrated material with the first leg portion folded intocontact with the second leg portion with the connector connecting thefirst leg portion to the second leg portion and forming a closed spacebetween the first leg portion and the second leg portion; locating theexterior surface of the vagina within the closed space; and whereinisolating the second end of the head section of the sacrocolpopexysupport from contact with tissue of the vagina comprises locating anentirety of the second end of the head section outside of the closedspace.
 4. The method of claim 1, wherein the sacrocolpopexy supportcomprises a line printed on one of the first leg portion and the secondleg portion, the method further comprising: orienting the line relativeto the exterior surface of the vagina; and attaching the one of thefirst leg portion and the second leg portion to the exterior surface ofthe vagina.
 5. The method of claim 1, wherein the sacrocolpopexy supportcomprises a line printed on one of the first leg portion and the secondleg portion, the method further comprising: centering the line relativeto the exterior surface of the vagina; and attaching the one of thefirst leg portion and the second leg portion to the exterior surface ofthe vagina.
 6. The method of claim 1, further comprising reducing apossibility of the head section rubbing against the exterior surface ofthe vagina.
 7. The method of claim 1, further comprising preventing thehead section rubbing against the exterior surface of the vagina.
 8. Themethod of claim 1, wherein the vaginal cuff section of thesacrocolpopexy support has a first basis weight and the head section isa heavier basis weight section having a second basis weight that islarger than the first basis weight, the method further comprising:isolating the heavier basis weight section of the head section away fromthe exterior surface of the vagina.
 9. The method of claim 1, furthercomprising suturing the head section of the sacrocolpopexy support toone of the ligament and the sacrum.
 10. The method of claim 1, furthercomprising stapling the head section of the sacrocolpopexy support toone of the ligament and the sacrum.
 11. The method of claim 1, furthercomprising tacking the head section of the sacrocolpopexy support to oneof the ligament and the sacrum.
 12. The method of claim 1, furthercomprising suturing the first leg portion and the second leg portion ofthe vaginal cuff section to the exterior surface of the vagina.